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Tuesday, April 30, 2024

Michigan: Biologics companies were the second most FDA inspected companies in Michigan in Q3 2023

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In the third quarter of 2023, six Biologics companies received six FDA inspections in Michigan, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Michigan, equalling 10.5% of all inspections in the third quarter of 2023.

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

The FDA is a government agency primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

FDA Inspections in Michigan During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring4----
Blood and Blood Products5----
Compliance: Devices--1--
Food Composition, Standards, Labeling and Econ3--1
Foodborne Biological Hazards2672
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Technical Assistance: Food and Cosmetics142--
Unapproved and Misbranded Drugs----1

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